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Outsourcing Clinical Trials
Gaining Popularity
The skyrocketing cost of drug development over the past decade, coupled with
stiff competition for limited numbers of potential trial participants, has
compelled pharmaceutical and biotechnology companies to seek more cost effective
ways of conducting clinical research. This quest has led to outsourcing clinical
trials to developing countries where large numbers of qualified patient
volunteers await, the cost of doing business is far cheaper, and new
therapeutics can be brought to market faster.
The cold, hard facts are that:
-
Clinical trials conducted in the
U.S. typically cost about $150
million, 60% more than in India,
according to a study by Rabo
Bank.[1]
-
Recruitment time can be halved,
a significant advantage to
sponsors seeking hundreds, and
in some cases thousands, of
clinical trial participants.[1]
-
India's billion-plus population
offers tremendous genetic
diversity, and a large patient
population that has never
received drug treatment,
simplifying patient enrollment
and trial management.[1]
-
Whereas Western patients are
often wary of participating in
clinical trials, many in India
are eager to enroll in order to
gain access to free medical care
and tests, as well as drugs they
could not otherwise afford.[1]
-
China, too, is becoming an
increasingly popular site for
clinical trials, with sponsors
drawn by its “potentially
lucrative market for new drugs,
which some estimate will be
worth $50 billion in five
years.”
[3]
-
“In the first half of 2003,
applications for clinical trials
soared 420 percent over the year
before to almost 2,500,”
according to China's Department
of Drug Registration. Demand is
so great that dozens of
hospitals are being added to the
165 already permitted to conduct
human clinical trials.[3]
Dangers inherent in outsourcing
clinical trials to developing
countries:
-
Review boards that oversee
trials in developing countries
often don't include ethicists
and “favor the interests of
doctors and hospitals,” says Li
Benfu, president of the Chinese
Medical Ethics Association.[3]
-
Rapid growth in new trials may
be overwhelming regulators in
China.[3]
-
Poor practices, an underfunded
medical system, poor enforcement
of regulations and widespread
poverty “threaten to erode trust
between China's sick and dying
and its medical establishment,
and undermine confidence in the
medical data that drug companies
collect in China.”[3]
-
Because foreign trial
participants have cultural,
nutritional, and economic
differences from the average
American participant,
precautions must be taken to
avoid skewing clinical trial
results. One such example is the
requirement that one-third of
the participants in any given
clinical trial must come from
the U.S. and/or Europe.
Ethical concerns abound
As clinical trials expand overseas,
ethics are a growing concern, with
debate focused on the possible
exploitation and coercion of trial
volunteers. As a result, “drugs
might be approved for use in the
United States on the basis of
studies that don't meet U.S.
standards,” says Peter Lurie, Deputy
Director of the Public Citizen’s
Health Research Group, a consumer
advocacy group based in Washington
DC.
The FDA is considering the adoption
of less restrictive rules for
clinical research conducted outside
the U.S. These changes would:
-
Allow the use of placebos in
clinical trials to “assess the
effectiveness of a drug, even
when there is a known effective
treatment for the condition.”
-
Eliminate the requirement that
clinical trial participants be
given the best available
treatment for their condition
after the trial has ended. This
is popular with drug companies
who “don’t want to be saddled
with responsibility to patients
after studies are done,” said
Lurie.
-
Exempt overseas trials from
adherence to the Declaration of
Helsinki, a code of medical
ethics created by 82 national
medical associations, to protect
trial participants.
-
Require overseas trials need
only comply with “good clinical
practices,” which is much weaker
regarding patient protections.
“The Declaration of Helsinki is the
standard-bearer for international
research ethics and enjoys
particular respect in the developing
world,” Lurie said. “It would be
tragic if the US tendency to
arrogantly flout international laws
claimed the declaration as another
victim, even as the President touts
the universalism of human rights.”[4]
Despite everything, for India, the
potential benefits of clinical
research are far greater than its
hazards, says Rajesh Jain, Managing
Director of drug maker Panacea
Biotec Ltd. “It brings in the best
in industry practices in clinical
research for the benefit of our
population's health-care needs while
exposing the medical community to
global processes and standards.”[1]
Sources:
[1]
http://www.atimes.com/atimes/South_Asia/FG23Df03.html;
India's clinical trials and
tribulations By Indrajit Basu;
Asia Times online, July 23,
2004
[2]
Drug Companies Cut Costs With
Foreign Clinical Trials By
SARITHA RAI The New York Times,
February 24, 2005.
[3]
Meds And Miracles:
China's medical system is straining
to accommodate a flood of Western
firms testing new medicines. By
Craig Simons Newsweek
International ,April 11/18 issue
[4]
http://www.news-medical.net/?id=8698;
US tendency to arrogantly flout
international ethical practice for
patient trials abroad;
Pharmaceutical News;
Published: Monday, 28-Mar-2005
[5]
FDA Considers Changes For
Offshore Drug Trials; Wall
Street Journal, March 28, 2005
[6]
FDA Seeks Weaker Ethics Rules for
Medical Trials, Critics Claim,
March 24, 2005 |
